New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

03/20/2008

Trade Name:

Zometa

Generic Name or Proper Name (*):

zoledronic acid

Indications Studied:

Severe osteogenesis imperfecta

Label Changes Summary:

* Zoledronic acid is not indicated for use in children * Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain * Information on PK, clinical study, and AE profile